Study of Etanercept in the Treatment of Psoriasis in Adult Subjects

NCT00121615

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammation, Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who completed study 20030115 or 20030117 qualify to enroll into this study (provided that they meet all inclusion/exclusion criteria). - Heterosexually active men and women of child-bearing potential must agree to use a medically acceptable form of contraception throughout the study. - Subject or designee must have the ability to self-inject investigational product. - Subject must be capable of understanding and giving written voluntary informed consent. - Negative serum pregnancy test less than or equal to 14 days prior to the first dose of investigational product in all female subjects (except those surgically sterile or at least 5 years postmenopausal)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Active guttate, erythrodermic, or pustular psoriasis at the time of
the baseline visit - Any adverse event or infection at the time of the baseline visit or at
any time during the previous etanercept psoriasis study which, in the opinion of Amgen or
the Investigator, would preclude participation in the study - Presence of a serious
infection less than or equal to 30 days prior to the baseline visit - Evidence of skin
conditions at the baseline visit (e.g., eczema) that would interfere with evaluations of
the effect of investigational product on psoriasis - Previous receipt of anti-TNF agent(s)
other than etanercept - Receipt of any investigational product(s), other than etanercept,
less than or equal to 30 days prior to first dose of investigational product in this study
- Receipt of anti-CD4 or diphtheria IL-2 fusion protein less than or equal to 24 weeks
prior to first dose of investigational product in this study - Psoralen and ultraviolet A
(PUVA) light therapy less than or equal to 14 days prior to first dose of investigational
product in this study - Ultraviolet A (UVA) light therapy less than or equal to 14 days
prior to first dose of investigational product in this study - Ultraviolet B (UVB) light
therapy less than or equal to 14 days prior to first dose of investigational product in
this study - Receipt of any other systemic psoriasis therapy or oral or parenteral
corticosteroids less than or equal to 14 days prior to first dose of investigational
product in this study - Pregnant or breast-feeding females - Significant concurrent medical
conditions prior to enrollment, including: uncontrolled hypertension (defined as systolic
blood pressure measurement of greater than 180 mm Hg or an untreated diastolic blood
pressure of greater than 110 mm Hg); myocardial infarction less than or equal to 52 weeks
prior to baseline visit; unstable angina pectoris; uncompensated congestive heart failure;
severe pulmonary disease requiring hospitalization or supplemental oxygen therapy;
diagnosis of multiple sclerosis or any other demyelinating disease; insulin-dependent
diabetes mellitus; history of cancer (other than in-situ cervical cancer or resected
cutaneous basal cell or squamous cell carcinoma) less than or equal to 5 years prior to
administration of first dose of investigational product; open cutaneous ulcers; known human
immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis C virus
(HCV) positive; any condition that might cause this study to be detrimental to the subject,
in the judgment of the investigator.

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Inflammation, PsoriasisStudy of Etanercept in the Treatment of Psoriasis in Adult Subjects
NCT00121615
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Etanercept in the Treatment of Psoriasis in Adult Subjects
Official Title  ICMJE An Open-Label, Long-Term Extension Study to Assess the Safety and Efficacy of Etanercept in the Treatment of Psoriasis in Adult Subjects
Brief Summary The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammation
  • Psoriasis
Intervention  ICMJE Drug: etanercept
Study Arms  ICMJE Not Provided
Publications * Papp KA, Poulin Y, Bissonnette R, Bourcier M, Toth D, Rosoph L, Poulin-Costello M, Setterfield M, Syrotuik J. Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population. J Am Acad Dermatol. 2012 Feb;66(2):e33-45. doi: 10.1016/j.jaad.2010.07.026. Epub 2010 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 27, 2007)
391
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Inclusion Criteria: - Subjects who completed study 20030115 or 20030117 qualify to enroll into this study (provided that they meet all inclusion/exclusion criteria). - Heterosexually active men and women of child-bearing potential must agree to use a medically acceptable form of contraception throughout the study. - Subject or designee must have the ability to self-inject investigational product. - Subject must be capable of understanding and giving written voluntary informed consent. - Negative serum pregnancy test less than or equal to 14 days prior to the first dose of investigational product in all female subjects (except those surgically sterile or at least 5 years postmenopausal) Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the baseline visit - Any adverse event or infection at the time of the baseline visit or at any time during the previous etanercept psoriasis study which, in the opinion of Amgen or the Investigator, would preclude participation in the study - Presence of a serious infection less than or equal to 30 days prior to the baseline visit - Evidence of skin conditions at the baseline visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis - Previous receipt of anti-TNF agent(s) other than etanercept - Receipt of any investigational product(s), other than etanercept, less than or equal to 30 days prior to first dose of investigational product in this study - Receipt of anti-CD4 or diphtheria IL-2 fusion protein less than or equal to 24 weeks prior to first dose of investigational product in this study - Psoralen and ultraviolet A (PUVA) light therapy less than or equal to 14 days prior to first dose of investigational product in this study - Ultraviolet A (UVA) light therapy less than or equal to 14 days prior to first dose of investigational product in this study - Ultraviolet B (UVB) light therapy less than or equal to 14 days prior to first dose of investigational product in this study - Receipt of any other systemic psoriasis therapy or oral or parenteral corticosteroids less than or equal to 14 days prior to first dose of investigational product in this study - Pregnant or breast-feeding females - Significant concurrent medical conditions prior to enrollment, including: uncontrolled hypertension (defined as systolic blood pressure measurement of greater than 180 mm Hg or an untreated diastolic blood pressure of greater than 110 mm Hg); myocardial infarction less than or equal to 52 weeks prior to baseline visit; unstable angina pectoris; uncompensated congestive heart failure; severe pulmonary disease requiring hospitalization or supplemental oxygen therapy; diagnosis of multiple sclerosis or any other demyelinating disease; insulin-dependent diabetes mellitus; history of cancer (other than in-situ cervical cancer or resected cutaneous basal cell or squamous cell carcinoma) less than or equal to 5 years prior to administration of first dose of investigational product; open cutaneous ulcers; known human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV) positive; any condition that might cause this study to be detrimental to the subject, in the judgment of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00121615
Other Study ID Numbers  ICMJE 20040216
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Global Development Leader, Amgen Inc.
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:MDAmgen
PRS Account Amgen
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP